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Treosulfane

Phase 2

Prostate Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Nov 21, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

Treosulfane · 1 trial · 1 indication

Phase 2 1
NCT00427999Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate CancerProstate Cancer
COMPLETED67 Analytics
PHASE2COMPLETED
Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

PSA Response Rate
up to 24 weeks

To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for \> 5 ng/ml.

Secondary Endpoints

Time to PSA Response
every 4 weeks up to 24 weeks
Time to Progression-free Survival
every 4 weeks up to 24 weeks
Overall Survival Rate
every 4 weeks up to 24 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfaneEXPERIMENTALSTI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Interventions

NameTypeDescription
imatinib mesylateDRUG -
TreosulfaneDRUG -
etoricoxibDRUG -
pioglitazoneDRUG -
dexamethasoneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites10

Inclusion criteria: * Histologically confirmed prostate carcinoma, which has proven progression after primary hormone therapy (surgical or medicinal castration). * Patients must have increasing PSA levels (within 3 months prior to enrollment) with at least two consecutively increasing PSA levels. *...

Countries:Germany
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Treosulfane

What is Treosulfane used for in prostate cancer?

Treosulfane is an investigational small molecule being studied for the treatment of prostate cancer, specifically in patients with hormone-refractory prostate cancer. It is being evaluated as part of a combined anti-inflammatory and angiostatic therapy approach. The drug is currently in Phase 2 clinical development and is not yet approved.

What does Treosulfane target?

Treosulfane is a small molecule with anti-inflammatory and angiostatic properties. It is being studied for its potential to inhibit angiogenesis and reduce inflammation in the context of hormone-refractory prostate cancer. However, its specific molecular target has not been disclosed in the available information.

Who makes Treosulfane?

Treosulfane is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with prostate cancer.

What phase is Treosulfane in?

Treosulfane is in Phase 2 clinical development. It has completed one Phase 2 trial in patients with hormone-refractory prostate cancer. The drug is still investigational and has not received regulatory approval for any indication.

What clinical trials is Treosulfane in?

Treosulfane has been studied in one clinical trial with the identifier NCT00427999. This Phase 2 trial, titled 'Combined Antiinflammatory and Angiostatic Therapy in Patients With Hormone-refractory Prostate Cancer,' was completed in Germany and enrolled 67 male patients aged 18 years and older.

Is Treosulfane the same as Treosulfan?

Treosulfane is also known as Treosulfan. Both names refer to the same drug substance. In clinical literature and trial registries, the drug may be listed under either name, but they are interchangeable.